Kodell R L
Division of Biometry and Risk Assessment, National Center for Toxicological Research, Food and Drug Administration, Jefferson, Arkansas 72079, USA.
Drug Metab Rev. 1996 Feb-May;28(1-2):219-23. doi: 10.3109/03602539608994001.
Bioassays that include various types of discontinuous exposure to carcinogens are somewhat rare and are far from routine. However, discontinuous-dosing groups represent a valuable enhancement of the ordinary bioassay design. My hope is that efforts to include discontinuous-exposure groups in cancer-bioassays will become widespread, and that discontinuous-dosing designs will eventually be a matter of routine. To me, such designs represent an easy (although perhaps costly) way to increase the sophistication of the tumor incidence data for model fitting, and to provide valuable data for validating (or perhaps invalidating) postulated mathematical models of the cancer process. Certainly discontinuous-dosing data at least provide a valuable ancillary resource to be utilized along with data on postulated mechanisms in the effort to implement biologically based models of the cancer process for quantitative risk assessment. Such data might even be indispensible.
包含各种类型的致癌物间断暴露的生物测定相对较少，远非常规操作。然而，间断给药组是对普通生物测定设计的有价值的改进。我希望在癌症生物测定中纳入间断暴露组的努力能够得到广泛开展，并且间断给药设计最终将成为常规操作。对我来说，这样的设计是一种简单（尽管可能成本较高）的方法，可以提高用于模型拟合的肿瘤发生率数据的复杂性，并为验证（或可能推翻）癌症发生过程的假定数学模型提供有价值的数据。当然，间断给药数据至少提供了一种有价值的辅助资源，可与关于假定机制的数据一起用于努力实施基于生物学的癌症发生过程模型以进行定量风险评估。这样的数据甚至可能是不可或缺的。
